Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R03AG056460 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
Investigators plan a prospective cohort study with an adaptive design based on physical function status. The design will involve tracking the number of women recruited with physical function impairment and those without any functional impairment. Investigators aim to recruit similar numbers of women in each group. If investigators find unequal numbers, they will adapt recruit strategies based on a woman's functional status.
Investigators plan a prospective cohort study with an adaptive design based on physical function status. The design will involve tracking the number of women recruited with physical function impairment and those without any functional impairment. Investigators aim to recruit similar numbers of women in each group. If they find unequal numbers, they will adapt recruit strategies based on a woman's functional status.
Investigators will compare changes in outcome measures within and between groups after 6 and 12 weeks of pelvic floor muscle exercises (PFME). The change in pelvic floor strength/efficiency will be assessed by repeating the pelvic floor PERFECT assessment and will be compared between groups. Changes in UI symptoms, symptom severity, and impact of UI symptoms on quality of life will be determined using standardized measures described above. Data analysis will define associations between changes in PERFECT measures and the change in UI episodes (based on 3-day voiding diary), severity, and type (based on QUID-7), and impact on quality of life (PFIQ-7) within and between groups. Objective measurement of lower-extremity strength will inform the relationship between lower-extremity strength, pelvic floor strength, and UI symptoms at baseline and the 6-week visit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functionally impaired | Active Comparator | Women with urinary incontinence and short physical performance battery score of <9 |
|
| Functionally normal | Placebo Comparator | Women with urinary incontinence and short physical performance battery score of > 10 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor muscle exercise | Behavioral | Standardized pelvic floor muscle exercise regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Urinary Incontinence Episodes | Using a three-day voiding diary | Baseline |
| Number of Urinary Incontinence Episodes | Using a three-day voiding diary | week 6 |
| Number of Urinary Incontinence Episodes | Using a three-day voiding diary | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Power of Contractions | measurement of strength using perineometer | week 12 |
| Endurance | measure of how long they can hold contraction |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Organ Prolapse | measured using the standardized Pelvic Organ Prolapse Quantification (POP-Q) system | baseline, week 12 |
| Short Physical Performance Battery (expSPPB)--Gait Speed | expSPPB scores range from zero to 12 possible points. SPPB score of 0 indicates the lowest physical performance, and a score of 12 indicates the highest performance |
Inclusion Criteria:
Exclusion Criteria:
Must be born a woman due to the nature of the intervention investigators are studying.
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Candace Parker-Autry, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35852275 | Derived | Parker-Autry C, Neiberg R, Leng XI, Matthews CA, Dumoulin C, Kuchel G, Kritchevsky SB. Examining the Role of Nonsurgical Therapy in the Treatment of Geriatric Urinary Incontinence. Obstet Gynecol. 2022 Aug 1;140(2):243-251. doi: 10.1097/AOG.0000000000004852. Epub 2022 Jul 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Functionally Impaired | Women with urinary incontinence and short physical performance battery score of <9 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen |
| FG001 | Functionally Normal | Women with urinary incontinence and short physical performance battery score of > 10 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Functionally Impaired | Women with urinary incontinence and short physical performance battery score of <9 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen |
| BG001 | Functionally Normal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Urinary Incontinence Episodes | Using a three-day voiding diary | Posted | Mean | Standard Deviation | number of incontinence episodes | Baseline |
|
Collected from baseline through week 12
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Functionally Impaired | Women with urinary incontinence and short physical performance battery score of <9 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Candace Parker-Autry, MD | Wake Forest University School of Medicine | 336-716-3779 | candace.parkerautry@wfusm.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2019 | Oct 9, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 18, 2019 | Mar 17, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
This will be determined based on the score on the SPPB.
Not provided
Not provided
Not provided
Not provided
| week 12 |
| Repetition of Contractions | how many repetitions can they sustain | week 12 |
| Number of Fast Contractions | number of fast contractions that can be repeated | week 12 |
| week 12 |
| 400 Meter Walk | measurement of exercise tolerance | week 12 |
| Isokinetic Dynamometer | maximal isokinetic knee extensor strength in the right leg will be measured at speeds of 60 degrees/sec. The left leg will be used if there is a reason not to measure the right leg. | week 12 |
| Postural Sway | Center-of-Pressure (COP) trajectory data will be collected using an Advanced Mechanical Incorporated (AMTI) AccuSway biomechanics force platform. Participants will be barefoot in an upright stance with arms raised comfortably at their sides, feet abducted, and heels separated. Four posturographic parameters (maximum antero-posterior and medio-lateral displacement, average sway velocity, and 95% confidence ellipse) and two statistical mechanics measures (stabilogram diffusion analysis and detrended fluctuation analysis) will be calculated to quantify postural sway according to our previously published methods. | week 12 |
| Grip Strength | measure of weakness | week 12 |
| Gait Speed | Determined based on 4-meter walk at usual speed | week 12 |
| Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) Questionnaire | The SARC-F questionnaire is validated to identify adults with sarcopenia and who are at risk for adverse outcomes and may benefit from a physical function intervention. The scores range from 0 to 10, with 0 to 2 points for each component. A score equal to or greater than 4 is predictive of sarcopenia and poor outcome. | week 12 |
| Appendicular Lean Muscle Mass/Height | calculated based upon a whole-body DEXA scan performed in the Geriatric Research Unit | week 12 |
| Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire | a brief valid measure that assesses weekly frequency and duration of various physical activities common to older adults to evaluate the efficacy of behavioral interventions to increase levels of physical activity. Caloric expenditure (MET hours/week) will be reported.[8] 'Low activity' will be defined as <6.2 MET-hours/week of activity. Women with MET hr/week between 6.3 and 11.4 will be classified as low-moderate activity. Since only 23% of incontinent women had >11.4 MET hours/week of physical activity, this level will be defined as high activity. | week 12 |
| Barriers to Physical Activity Questionnaire | Questions regarding attitudes towards physical activity considering UI symptoms and perceived barriers will be assessed. 21-item measure assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63 with a higher score indicating a higher amount of perceived barriers. | week 12 |
| Mobility Assessment Tool-Short Form (MAT-SF) Score | This tool shows self-reported mobility. The score range is 30-80 and a higher score denotes better self-reported mobility. | week 12 |
| Abdominal Circumference | measure of abdominal circumference will be obtained to determine obesity severity | week 12 |
| Patient Global Impression of Improvement (PGI) | The PGI is a single-item, 7-point scale used to assess a patient's overall perception of their condition's change after treatment. Originating from the Clinical Global Impression-Improvement (CGI-I) scale used by clinicians, the PGI-I allows patients to rate their progress from "Very Much Improved" to "Very Much Worse," providing a simple, validated, and patient-centered outcome measure for various medical and psychiatric conditions. Scores range from 1 (Very Much Improved) to 7 (Very Much Worse). | week 12 |
| Patient Satisfaction Question | Participants are asked how satisfied they are with their progress in this program. Score ranges from 1 (Completely) to 3 (Not at all) | week 12 |
| Estimated Perception of Improvement Question | Participants estimate how much better they are on a scale from 0% (no better) to 100% (completely better). | week 12 |
| Montreal Cognitive Assessment (MoCA) | MoCA score ranges from 0 to 30 and is used as a screening tool for mild cognitive impairment. A score of 26 or over is considered to be normal. | week 12 |
Women with urinary incontinence and short physical performance battery score of > 10
Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Weight (kg) / Height (m)^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Urinary Incontinence Episodes | Using a three-day voiding diary | Posted | Mean | Standard Deviation | number of incontinence episodes | week 6 |
|
|
|
| Primary | Number of Urinary Incontinence Episodes | Using a three-day voiding diary | Posted | Mean | Standard Deviation | number of incontinence episodes | week 12 |
|
|
|
| Secondary | Power of Contractions | measurement of strength using perineometer | Posted | Mean | Standard Deviation | cmH2O | week 12 |
|
|
|
| Secondary | Endurance | measure of how long they can hold contraction | Posted | Mean | Standard Deviation | time in seconds | week 12 |
|
|
|
| Secondary | Repetition of Contractions | how many repetitions can they sustain | Posted | Mean | Standard Deviation | number of repetitions | week 12 |
|
|
|
| Secondary | Number of Fast Contractions | number of fast contractions that can be repeated | Posted | Mean | Standard Deviation | number of fast contractions | week 12 |
|
|
|
| Other Pre-specified | Pelvic Organ Prolapse | measured using the standardized Pelvic Organ Prolapse Quantification (POP-Q) system | Not Posted | baseline, week 12 | Participants |
| Other Pre-specified | Short Physical Performance Battery (expSPPB)--Gait Speed | expSPPB scores range from zero to 12 possible points. SPPB score of 0 indicates the lowest physical performance, and a score of 12 indicates the highest performance | Not Posted | week 12 | Participants |
| Other Pre-specified | 400 Meter Walk | measurement of exercise tolerance | Not Posted | week 12 | Participants |
| Other Pre-specified | Isokinetic Dynamometer | maximal isokinetic knee extensor strength in the right leg will be measured at speeds of 60 degrees/sec. The left leg will be used if there is a reason not to measure the right leg. | Not Posted | week 12 | Participants |
| Other Pre-specified | Postural Sway | Center-of-Pressure (COP) trajectory data will be collected using an Advanced Mechanical Incorporated (AMTI) AccuSway biomechanics force platform. Participants will be barefoot in an upright stance with arms raised comfortably at their sides, feet abducted, and heels separated. Four posturographic parameters (maximum antero-posterior and medio-lateral displacement, average sway velocity, and 95% confidence ellipse) and two statistical mechanics measures (stabilogram diffusion analysis and detrended fluctuation analysis) will be calculated to quantify postural sway according to our previously published methods. | Not Posted | week 12 | Participants |
| Other Pre-specified | Grip Strength | measure of weakness | Not Posted | week 12 | Participants |
| Other Pre-specified | Gait Speed | Determined based on 4-meter walk at usual speed | Not Posted | week 12 | Participants |
| Other Pre-specified | Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) Questionnaire | The SARC-F questionnaire is validated to identify adults with sarcopenia and who are at risk for adverse outcomes and may benefit from a physical function intervention. The scores range from 0 to 10, with 0 to 2 points for each component. A score equal to or greater than 4 is predictive of sarcopenia and poor outcome. | Not Posted | week 12 | Participants |
| Other Pre-specified | Appendicular Lean Muscle Mass/Height | calculated based upon a whole-body DEXA scan performed in the Geriatric Research Unit | Not Posted | week 12 | Participants |
| Other Pre-specified | Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire | a brief valid measure that assesses weekly frequency and duration of various physical activities common to older adults to evaluate the efficacy of behavioral interventions to increase levels of physical activity. Caloric expenditure (MET hours/week) will be reported.[8] 'Low activity' will be defined as <6.2 MET-hours/week of activity. Women with MET hr/week between 6.3 and 11.4 will be classified as low-moderate activity. Since only 23% of incontinent women had >11.4 MET hours/week of physical activity, this level will be defined as high activity. | Not Posted | week 12 | Participants |
| Other Pre-specified | Barriers to Physical Activity Questionnaire | Questions regarding attitudes towards physical activity considering UI symptoms and perceived barriers will be assessed. 21-item measure assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63 with a higher score indicating a higher amount of perceived barriers. | Not Posted | week 12 | Participants |
| Other Pre-specified | Mobility Assessment Tool-Short Form (MAT-SF) Score | This tool shows self-reported mobility. The score range is 30-80 and a higher score denotes better self-reported mobility. | Not Posted | week 12 | Participants |
| Other Pre-specified | Abdominal Circumference | measure of abdominal circumference will be obtained to determine obesity severity | Not Posted | week 12 | Participants |
| Other Pre-specified | Patient Global Impression of Improvement (PGI) | The PGI is a single-item, 7-point scale used to assess a patient's overall perception of their condition's change after treatment. Originating from the Clinical Global Impression-Improvement (CGI-I) scale used by clinicians, the PGI-I allows patients to rate their progress from "Very Much Improved" to "Very Much Worse," providing a simple, validated, and patient-centered outcome measure for various medical and psychiatric conditions. Scores range from 1 (Very Much Improved) to 7 (Very Much Worse). | Not Posted | week 12 | Participants |
| Other Pre-specified | Patient Satisfaction Question | Participants are asked how satisfied they are with their progress in this program. Score ranges from 1 (Completely) to 3 (Not at all) | Not Posted | week 12 | Participants |
| Other Pre-specified | Estimated Perception of Improvement Question | Participants estimate how much better they are on a scale from 0% (no better) to 100% (completely better). | Not Posted | week 12 | Participants |
| Other Pre-specified | Montreal Cognitive Assessment (MoCA) | MoCA score ranges from 0 to 30 and is used as a screening tool for mild cognitive impairment. A score of 26 or over is considered to be normal. | Not Posted | week 12 | Participants |
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Functionally Normal | Women with urinary incontinence and short physical performance battery score of > 10 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen | 0 | 37 | 0 | 37 | 0 | 37 |
Not provided
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |